Advanced Impella SmartAssist System for Subject Monitoring and Treatment: An Early Feasibility Study
Study of the Impella SmartAssist in Participants Undergoing High Risk Percutaneous Coronary Intervention (HRPCI)
Sponsor: Abiomed Inc.
Enrolling: Male and Female Patients
IRB Number: AAAT2216
U.S. Govt. ID: NCT04465201
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: The purpose of this research study is to evaluate if it is safe and feasible to use the Impella Hemodynamic Platform to measure and display hemodynamic parameters (measurements of how much pressure the heart is generating and how much blood your heart is pumping) during PCI procedures. PCI is a surgical procedure that uses a catheter (a thin flexible tube) to place a small structure called a stent to open up blood vessels in the heart that have been narrowed by plaque buildup. The Impella device will be placed via the a femoral artery and delivers up to 3.5 liters of blood per minute to the heart. During its placement, the Impella CP with SmartAssist is positioned in such a way that will allow for the required measurements.
Investigator
Jeffrey Moses, MD
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366